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Clinical Evidence

Peer-Reviewed
Publications

As Lexington Medical grows, our customers around the globe see improved clinical outcomes verses previous stapling products. Surgeons have devoted time to both driving prospective studies and to collecting retrospective data in pursuit of objectively assessing AEON™ clinical performance versus the competition to determine whether AEON™ can deliver better outcomes for both patients and their institutions. The real-world evidence continues to mount as studies reveal the clinical superiority associated with our staple line.

Walton Publication Superior staple line AEON - SLEPT

Evaluation of Alternate Laparoscopic Stapling Device for Bariatric Surgery

Walton, Gregory F. MD; Broussard, Toby D. MD - August, 2023

Surgical Laparoscopy, Endoscopy & Percutaneous Techniques

 

Abstract

Background: As laparoscopic bariatric surgical techniques have matured, the incidence of complications has decreased over time. Surgical stapling devices are commonly used for resection and anastomosis of gastric tissue during bariatric surgery. The purpose of this study is to assess and compare complication rates and clinical outcomes between patient cohorts using 2 different approved stapling devices.

Materials and Methods: Clinical outcomes were retrospectively compared for patients undergoing bariatric surgery between April 2019 and December 2020 using laparoscopic surgical stapling device A (LSSD-A) against outcomes between January 2017 and September 2018 using laparoscopic surgical stapling device B (LSSD-B). Tradenames for LSSD-A and LSSD-B were AEON Endostapler and Endo GIA with Tri-Staple Technology, respectively.

Results: In all, 814 patients underwent laparoscopic bariatric operation using LSSD-A and 1034 using LSSD-B. Laparoscopic surgery included… Continue Reading

Sheen Publication on AEON superior clinical outcomes - Frontiers in Oncology

Preliminary experience in laparoscopic distal pancreatectomy using the AEON™ endovascular stapler

Aali J. Sheen; Samik Bandyopadhyay; Minas Baltatzis; Rahul Deshpande; Saurabh Jamdar; Nicola de Liguori Carino - April 2023

Frontiers in Oncology

 

Abstract

Background: The aim of this study is to investigate the effects of using a new innovative endovascular stapler, AEON™, on the pancreatic leak rates and other outcome measures.

Methods: In a retrospective review of prospectively collected data from a secure tertiary unit registry, patients undergoing distal or lateral pancreatectomy were analyzed for any differences on pancreatic fistula rates, length of stay, comprehensive complication index (CCI), and demographics after using AEON™ compared with other commonly used staplers. Statistical significance was defined as <0.05.

Results: There were no differences in the demographics between the two groups totaling 58 patients over 2 years from 2019 to 2021. A total of 43 and 15 patients underwent pancreatic transection using other staplers and AEON™ endovascular stapler, respectively. The comparison of the two groups revealed a significantly reduced rate of mean drain lipase at postoperative day 3 with AEON™ (446 U/L) versus the other staplers (4,208 U/L) (p = 0.018) and a subsequent reduction of… Continue Reading

Raftopoulos Publication - Obesity Surgery

Prospective Randomized Comparison of Linear Endostaplers During Laparoscopic Sleeve Gastrectomy

Yannis Raftopoulos; Shruthi Rajkumar; Elana Davidson; and Pavlos Papasavas - August, 2022

Obesity Surgery

 

Abstract

Purpose: The development of Laparoscopic Linear Endostaplers (LLES) is crucial in minimally invasive approaches in bariatric surgery, but there have been very few published studies comparing 6-row LLES in Laparoscopic Sleeve Gastrectomy (LSG). The objective of this study was to compare two 6-row LLES in LSG.

Methods: A total of 60 patients were prospectively randomized to undergo LSG with either Medtronic Endo GIA™ Tri-Staple technology (MTS) or AEON ™ Endostapler(Lexington Medical) LLES. The measured parameters included patient demographics, comorbidity indices, LLES and specimen characteristics, postoperative symptoms, hospital stay, and total adverse events (AEs). Intraoperative bleeding was evaluated using five laparoscopic and corresponding endoscopic images of staple line before clip application, compared with a 1–5 Visual Analogue Scale (VAS), assessed by an independent bariatric surgeon who was blinded to the LLES used. Images of all cases were reviewed on the same day to increase test–retest reliability.

Results: Both groups were similar in patient demographics. Compared to MTS, AEON LLES group had significantly lower bleeding… Continue Reading

Redmann Publication - JSLS on superior hemostasis with the Lexington Medical AEON Endostapler

Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler

James G. Redmann, MD; Thomas E. Lavin, MD; Matthew S. French, MD; Toby D. Broussard, MD; and Maxime Lapointe-Gagner, BSc - December, 2020

Journal of The Society of Laparoscopic & Robotic Surgeons

 

Abstract

Background: Staple line bleeding can be a major intra-operative complication during laparoscopic sleeve gastrectomy, requiring reinforcing interventions that may diminish the integrity of the staple line and put patients at risk for postoperative hemorrhage or leak. To improve outcomes associated with surgery, surgeons may benefit from an alternative stapler that produces a drier staple line and requires less staple line manipulation.

Methods: Sixty consecutive laparoscopic sleeve gastrectomy procedures were performed by three surgeons; 30 sleeves using the AEON™ Endostapler on THICK MODE and 30 using the Echelon Flex™ Powered Stapler with pulse technique. Stapler performance was measured by incidence and degree of staple line bleeding. Images of the first firing and fundus were taken with the laparoscope 10 seconds after the final firing. Images were evaluated by a third-party blinded evaluator and given a “bleeding score,” a qualitative measure of intra-operative staple-line bleeding (1 = no bleeding to 5 = profuse bleeding).

Results: The AEON™ Endostapler demonstrated a lower mean (± standard error) “bleeding score” versus the Echelon Flex™… Continue Reading

Interested in Collaborating?

We continuously seek surgeon partners who are interested in studying clinical outcomes associated with AEON™. Please share your proposed research project so we can continue to bring innovation to surgical stapling together.

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Lexington Medical, Inc.

23 Crosby Drive

Bedford, MA 01730

Tel: 617.209.9817

Lexington Medical ANZ Pty Ltd

171 Clarence Street

Sydney, NSW 2000

Lexington Medical do Brasil Ltda

Alameda Africa, 337

Tambore, Santana de Parnaiba – São Paulo

06543-306

Lexington Medical UK Ltd.

73 Cornhill 

London, EC3V 3QQ

Tel: +44 (0) 20 7299 1400

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Roosstrasse 53

CH-8832 Wollerau

Tel: +41 44 533 63 00

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